PULL TAB SQUEEZE FLUSH

Catheter, Continuous Flush

ICU MEDICAL, INC

The following data is part of a premarket notification filed by Icu Medical, Inc with the FDA for Pull Tab Squeeze Flush.

Pre-market Notification Details

Device IDK070979
510k NumberK070979
Device Name:PULL TAB SQUEEZE FLUSH
ClassificationCatheter, Continuous Flush
Applicant ICU MEDICAL, INC 4455 ATHERTON DR. Salt Lake City,  UT  84123
ContactTracy Best
CorrespondentTracy Best
ICU MEDICAL, INC 4455 ATHERTON DR. Salt Lake City,  UT  84123
Product CodeKRA  
CFR Regulation Number870.1210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-04-06
Decision Date2007-09-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10887709088570 K070979 000
10840619027787 K070979 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.